[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Proposed Rules]
[Pages 7109-7114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2841]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[Docket No. CDC-2012-0002]
RIN 0920-AA47
Establishment of User Fees for Filovirus Testing of Nonhuman
Primate Liver Samples
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of Proposed Rulemaking and request for comments.
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SUMMARY: Through this Notice of Proposed Rulemaking (NPRM), the Centers
for Disease Control and Prevention (CDC), located within the Department
of Health and Human Services (HHS) is proposing to establish a user fee
for filovirus testing of all nonhuman primates that die during the HHS/
CDC-required 31-day quarantine period for any reason other than trauma.
We propose to establish a filovirus testing service at HHS/CDC because
testing is no longer being offered by the only private, commercial
laboratory that previously performed these tests. This testing service
will be funded through user fees. Elsewhere in this issue of the
Federal Register, HHS/CDC is simultaneously publishing a companion
direct final rule that proposes identical filovirus testing and user
fee requirements in this Federal Register because it believes that
these requirements are non-controversial and unlikely to generate
significant adverse comment. If HHS/CDC does not receive any
significant adverse comment on the direct final rule within the
specified comment period, it will publish a notice in the Federal
Register withdrawing this notice of proposed rulemaking and confirming
the effective date of the direct final rule within 30 days after the
end of the comment period on the direct final rule. If HHS/CDC receives
any timely significant adverse comment, it will withdraw the direct
final rule in part or in whole by publication of a notice in the
Federal Register within 30 days after the comment period ends and
proceed with notice and comment under this notice of proposed
rulemaking. A significant adverse comment is one that explains: Why the
direct final rule is inappropriate, including challenges to the rule's
underlying premise or approach; or why the direct final rule will be
ineffective or unacceptable without a change.
DATES: Submit written or electronic comments by April 10, 2012.
ADDRESSES: You may submit comments, identified by ``RIN 0920-AA47'': By
any of the following methods:
Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
Mail: Division of Global Migration and Quarantine, Centers
for Disease Control and Prevention, 1600 Clifton Road NE., MS-03,
Atlanta, Georgia 30333, ATTN: NHP NPRM.
Instructions: All submissions received must include the agency name
and docket number or Regulation Identifier Number (RIN) for this
rulemaking. All comments will be posted without change to http://regulations.gov, including any personal information provided. For
detailed instructions on submitting comments and additional information
on the rulemaking process, see the ``Public Participation'' heading of
the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, please go to http://www.regulations.gov. Comments
will be available for public inspection Monday through Friday, except
for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600
Clifton Road NE., Atlanta, Georgia 30333. Please call ahead to 1-866-
694-4867 and ask for a representative in the Division of Global
Migration and Quarantine (DGMQ) to schedule your visit. To download an
electronic version of the rule, access http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For questions concerning this notice
of proposed rulemaking: Ashley A. Marrone, JD, Centers for Disease
Control and Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta,
Georgia 30333; telephone 404 498-1600. For information concerning
program operations: Dr. Robert Mullan, Centers for Disease Control and
Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia
30333; telephone 404 498-1600.
SUPPLEMENTARY INFORMATION: This preamble is organized as follows:
I. Public Participation
II. Background
III. Rationale for Proposal
IV. User Fee
V. Services and Activities Covered by This User Fees
VI. Analysis of User Fee Charge (Cost to Government)
VII. Payment Instructions
VIII. Regulatory Analysis
IX. References
[[Page 7110]]
I. Public Participation
Interested persons are invited to participate in this rulemaking by
submitting written views, opinions, recommendations, and data. Comments
received, including attachments and other supporting materials, are
part of the public record and subject to public disclosure. Do not
include any information in your comment or supporting materials that
you do not wish to be disclosed publicly. Comments are invited on any
topic directly related to this proposed rule.
II. Background
Filoviruses belong to a family of viruses known to cause severe
hemorrhagic fever in humans and nonhuman primates (NHPs). So far, only
two members of this virus family have been identified: Ebola virus and
Marburg virus. Five species of Ebola virus have been acknowledged:
Zaire, Sudan, Reston, Ivory Coast, and Bundibugyo. Most strains of
Ebola virus can be highly fatal in humans, and while the Reston strain
is the only strain of filovirus that has not been reported to cause
disease in humans, it can be fatal in monkeys. (http://www.cdc.gov/ncidod/dvrd/spb/mnpages/dispages/filoviruses.htm).
Ebola hemorrhagic fever was first recognized in 1976, when two
epidemics occurred in southern Sudan and in Zaire. Since that time,
multiple outbreaks have occurred, mostly in Central Africa, and all
have been associated with high (45-90%) case-fatality rates in humans
(for an updated list see http://www.cdc.gov/ncidod/dvrd/spb/mnpages/dispages/ebola/ebolatable.htm). In these epidemics, transmission of the
disease originated or occurred in a hospital (often by contaminated
needles) and was followed by person-to-person transmission by
individuals who were exposed to, or had close contact with blood or
secretions from seriously ill patients.
The ecology, natural history, and mode of transmission of Ebola
virus in nature, and of the related Marburg virus, are becoming more
clearly understood with the implication of bats as reservoirs. The
incubation period for Ebola disease is 5-9 days (range: 2-15 days) but
can be shorter with parenteral transmission. Disease onset is abrupt
and characterized by severe malaise, headache, high fever, myalgia,
joint pains, and sore throat. The progression is rapid and includes
pharyngitis, conjunctivitis, diarrhea, abdominal pain, and occasionally
facial edema and jaundice. Severe thrombocytopenia can occur, with
hemorrhagic manifestations ranging from petechiae to frank bleeding.
Death occurs primarily as a result of multi-organ failures. There is no
specific therapy, and patient management is usually limited to
supportive measures. The disease in nonhuman primates is very similar
to that in humans, with a very high mortality.
On January 19, 1990, in response to the identification of Ebola-
Reston virus in NHPs imported from the Philippines, HHS/CDC published
interim guidelines for handling NHPs during transit and also during
quarantine (1). Importers of NHPs were informed by letter from the HHS/
CDC Director on March 15, 1990, that they must comply with specific
isolation and quarantine standards under 42 CFR part 71 for continued
registration as an importer of NHPs (2).
On March 23, 1990, HHS/CDC held a meeting at CDC headquarters in
Atlanta, Georgia, at which the public could comment on new guidelines
for the importation of NHPs and the potential impact of a temporary ban
on the importation of cynomolgus monkeys into the United States (3).
After considering information received at this public meeting, coupled
with an April 4, 1990 confirmation of asymptomatic Ebola virus
infection in four NHP caretakers and serologic findings suggesting that
cynomolgus, African green, and rhesus monkeys posed a risk for human
filovirus infection, HHS/CDC concluded that these three species were
capable of being an animal host or vector of human disease (4).
As a result, on April 20, 1990, HHS/CDC published a notice in the
Federal Register requiring a special-permit for importing cynomolgus,
African green, and rhesus monkeys (5). To be granted a special-permit,
importers must submit a plan to HHS/CDC describing specific isolation,
quarantine, and communicable disease control measures. The plan must
detail the measures to be carried out at every step of the chain of
custody, from embarkation at the country of origin, through delivery of
the NHPs to the quarantine facility and the completion of the required
quarantine period. Additional requirements include detailed testing
procedures for all quarantined NHPs to rule out the possibility of
filovirus infection. When importers demonstrate compliance with these
special-permit requirements, HHS/CDC authorizes continued shipments
under the same permit for a period of 180 days. Certain components of
the special-permit requirement have changed slightly in response to
surveillance findings and the development of improved laboratory tests.
As indicated in the 1990 notice, importers were informed of these
changes by letter from HHS/CDC (6). The current special-permit notice
requires filovirus antigen-detection testing on liver specimens from
any NHP that dies during quarantine for reasons other than trauma (7,
8). Antibody testing is also required on surviving NHPs that exhibit
signs of possible filovirus infection before the cohort is released
from quarantine (9).
Since October 10, 1975, HHS/CDC has prohibited the importation of
NHPs except for scientific, educational, or exhibition purposes. Over
time, various measures (e.g., reports, letters, guidelines, notices),
have been used to support implementation of these regulations. On
January 5, 2011, HHS/CDC posted a Notice of Proposed Rulemaking (NPRM)
to begin the process of revising these requirements. The NPRM was
intended to solicit public comment and feedback on the issue of NHP
importation to determine the need for further rulemaking. Please see
the docket details for HHS-OS-2011-0002 on www.Regulations.gov, for
more information. The public comment period ended on April 25, 2011.
HHS/CDC is now working toward finalizing the proposed rule and is not
seeking additional comment on the NPRM through this rulemaking.
Laboratory testing of suspected NHPs and early detection of
infected animals within the quarantine period prevents spread of
disease among NHPs and caretakers (4). Since the implementation and
strengthening of the 1990 special-permit requirements for importing
nonhuman primates into the United States, the morbidity and mortality
of imported animals has decreased from an estimated 20% to less than 1%
(10). Since 1990, these laboratory tests have been conducted by a sole
commercial laboratory. Recently, a number of circumstances have arisen
such that this laboratory is no longer able to perform the testing for
filovirus required on liver specimens from monkeys that die during the
HHS/CDC-mandated quarantine. Further, HHS/CDC notes that the reagents
required for this testing are not commercially available and production
of the reagents requires a biosafety level 4 laboratory (BSL-4). A BSL-
4 laboratory is also required during part of the testing procedure. To
our knowledge, neither commercial entities nor Federal laboratories
other than those at HHS/CDC are planning to offer this service. Because
HHS/CDC has the required laboratory facility, access to the reagents,
and experienced personnel, it has started performing this testing when
[[Page 7111]]
required and in the absence of a viable alternative.
III. Rationale for Proposal
Through this NPRM, HHS/CDC is proposing to establish a user fee to
reimburse HHS/CDC for the costs incurred performing the required
filovirus testing and seeks public comment on this proposal. If
promulgated as proposed, upon the effective date of the final rule,
every NHP quarantine facility will be contacted by HHS/CDC's Division
of Global Migration and Quarantine (DGMQ), and will be instructed how
to transfer tissue specimens to HHS/CDC for testing. After receipt of
the specimens, HHS/CDC will process the specimens in its BSL-4
laboratory and test the specimens by an antigen-detection enzyme-linked
immunosorbant assay (ELISA) or other appropriate methodology. Each
specimen will be held for six months. After six months, the specimen
will be disposed of following established HHS/CDC protocol. Based on
information supplied by the commercial laboratory, HHS/CDC estimates
that between 100 and 150 specimens per year are expected to be received
and tested. Results will be provided to the NHP importers. If a
positive test result is found, HHS/CDC will ensure that the NHP cohort
is not released from HHS/CDC required quarantine until the health
status of the full cohort is determined. This testing protocol would be
maintained until further notice.
HHS/CDC has chosen to establish this testing service based on the
unanticipated loss of the only commercially available antigen-detection
ELISA filovirus testing facility. Currently, there are no commercially
available assays for filovirus antigen detection in tissue samples and
this testing cannot readily be performed in the private sector because
the testing requires a BSL-4 laboratory and the reagents are not
commercially available. Other factors which contribute to the necessity
of the testing service include the limited availability of BSL-4
laboratories, the special expertise required to perform these tests,
the lack of commercially-available reagents, the need and requirement
for continued and ongoing filovirus testing to protect public health,
the negative effect on science, education and exhibition if imports of
NHPs are disrupted, and the lack of other testing alternatives.
Nothing in this proposal is intended to prohibit a private sector
facility from developing the capability and offering this same service
in the future. The testing of non-human primate samples is necessary to
prevent and control a potential outbreak of a filovirus infection in
imported monkeys and to prevent the potential spread of filoviruses to
humans.
IV. User Fees
Title V of the Independent Offices Appropriation Act of 1952 (31
U.S.C. 9701) (``IOAA'') provides general authority to Federal agencies
to establish user fees through regulations. The IOAA sets parameters
for any fee charged under its authority. Each charge shall be:
(1) Fair; and
(2) Based on--
(A) The costs to the Government;
(B) The value of the service or thing to the recipient;
(C) Public-policy or interest served; and
(D) Other relevant facts.
OMB Circular A-25 (``the Circular'') establishes general policy for
implementing user fees, including criteria for determining amounts and
exceptions, and guidelines for implementation. According to the
Circular, its provisions must be applied to any fees collected pursuant
to the IOAA authority.
The Circular states that ``[a] user charge * * * will be assessed
against each identifiable recipient for special benefits derived from
Federal activities beyond those received by the general public.'' The
Circular gives three examples of when the special benefit is considered
to accrue, including when a Government service: (a) Enables the
beneficiary to obtain more immediate or substantial gains or values
(which may or may not be measurable in monetary terms) than those that
accrue to the general public (e.g., receiving a patent, insurance, or
guarantee provision, or a license to carry on a specific activity or
business or various kinds of public land use); or (b) provides business
stability or contributes to public confidence in the business activity
of the beneficiary (e.g., insuring deposits in commercial banks); or
(c) is performed at the request of or for the convenience of the
recipient, and is beyond the services regularly received by other
members of the same industry or group or by the general public (e.g.,
receiving a passport, visa, airman's certificate, or a Customs
inspection after regular duty hours).
The Circular sets forth guidelines for determining the amount of
user charges to assess. When the Government is acting in its sovereign
capacity, user charges should be sufficient to cover the full cost to
the Federal Government of providing the service, resource, or good.
The Circular sets forth criteria for determining full cost. ``Full
cost includes all direct and indirect costs to any part of the Federal
Government of providing a good, resource, or service.'' Examples of
these types of costs include, but are not limited to, direct and
indirect personnel costs, including salaries and fringe benefits;
physical overhead, consulting, and other indirect costs, including
material and supply costs, utilities, insurance, travel, and rents;
management and supervisory costs; and the costs of enforcement,
collection, research, establishment of standards, and regulation. Full
costs are determined based on the best available records of the agency.
Agencies are responsible for the initiation and adoption of user
charge schedules consistent with the guidance listed in the Circular.
In doing so, agencies should identify the services and activities
covered by the Circular; determine the extent of the special benefits
provided; and apply the principles set forth in the Circular in
determining full cost or market cost as appropriate.
Finally, CDC has legal authority to retain collected user fees
through its annual appropriations bill. In fiscal year 2012, this
authority is provided through the Consolidated Appropriations Act of
2012, Public Law 112-74, 125 Stat. 1069, 1070 (2011).
V. Services and Activities Covered by This User Fee
HHS/CDC is establishing a user fee to recoup the costs associated
with performing the required testing. The user fee will cover the costs
of the test for filovirus for specimens submitted to HHS/CDC. The
following is a list of services and activities that are covered by the
user fee:
Providing information to the participants about the
service, including instructions on submission of samples and payment;
Receiving payment and maintaining account, including
distributing funds;
Tracking the shipment to ensure a safe arrival at HHS/CDC;
Providing reagents for and performing the antigen-
detection test on submitted NHP liver samples in a BSL-4, high-
containment facility;
Performing all provided services in accordance with
industry standards, including quality assurance, handling and
processing procedures, and hazardous medical waste guidelines; and
Ensuring that the importer receives the test results in a
timely manner.
[[Page 7112]]
VI. Analysis of User Fee Charge (Cost to the Government)
HHS/CDC's analysis of costs to the Government is based on the
current methodology (ELISA) used to test NHP liver samples. This cost
determines the amount of the user fee. HHS/CDC notes that the use of a
different methodology or changes in the availability of ELISA reagents
will affect the amount of the user fee. HHS/CDC will impose the fee by
schedule and will notify importers of changes to the user fee by notice
in the Federal Register. Importers may also contact HHS/CDC at 404-498-
1600 or check its Web site (http://www.cdc.gov/animalimportation/) for
an up-to-date fee schedule.
In its analysis of cost, HHS/CDC considered five components: (1)
The cost of reagents and materials; (2) the cost of the BSL-4
laboratory in reagent production and during the assay; (3) the cost of
irradiation of the sample; (4) personnel costs to perform the testing;
and (5) administrative costs. The total cost to the Government is
summarized in Table 1 followed by a description of each component; all
monies reflected are in U.S. Dollars (USD).
Table 1--Summary Calculations of User Fee Charge-per-Test
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Costs
Components (USD)
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1. Use of reagents and other materials......................... $100
2. Use of BSL-4 lab facility................................... 112
3. Irradiation (inactivation) of sample........................ 150
4. Personnel costs to conduct testing.......................... 145
5. Administrative costs........................................ 33
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ESTIMATED TOTAL............................................ 540
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User Fee................................................... 540
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The first component in the estimate is the cost of the reagent
materials and other materials necessary to perform the test. Two
reagents are used to prepare the specific antibodies needed in the
test. These reagents are not commercially available and must be made
in-house by HHS/CDC scientists. Since these reagents are not
commercially available, there is no commercial or observable product
pricing. HHS/CDC estimates the cost for these reagents to be $70.00.
This amount includes the cost of production and validation of the
reagents. Material costs include plastic plates, pipettes, and other
reagents. These items are available commercially and their cost is
estimated at $30.00. Thus, the total estimated cost for this component
totals $100.00 per test. This cost can be a bit higher or lower
depending on how many tests are run at the same time. If the test
requests come in one at a time, then the cost might be above $100, if
there is more than one request at a time, the cost might be a bit less
than $100. The test calls for the same amount of reagents for one or 3
samples to test.
The second component is the cost of the BSL-4 facility that is used
to develop the reagents. We have estimated this cost on the charges
made by University of Texas Medical Branch at Galveston (UTMB) of $28
per hour. The UTMB is the only BSL-4 facility in the United States that
has developed commercial fees for the use of their labs. In the ELISA
methodology, scientists need four hours in the BSL-4 laboratory to
process the sample. The cost of this component is $112.00.
The third component in the cost estimate is the cost to inactivate
the sample by irradiation in an irradiator. For this component, we
estimate the cost to use an irradiator at $30 per hour. This estimate
is based on a five-year cost of $300,000 to HHS/CDC to run and maintain
the irradiator. Irradiators are extremely expensive to maintain for a
number of reasons. Only research facilities have irradiator equipment
because of the need to inactivate high-hazard pathogens. Safety
restrictions on irradiators are complex and time consuming; requiring
frequent, professional safety inspections and complex annual training
for all personnel that work with or near the irradiator. Finally, a
high level of security must be maintained because the complexities of
using irradiators and the specimens being irradiated require access to
be controlled and monitored. Typically it takes five hours to
inactivate a sample, at a total estimated irradiation cost of $150.
The fourth component of the cost is the hourly wage and benefits of
personnel who perform the laboratory tests. We assume that the
scientist performing the test is a microbiologist with a masters'
degree. Most of the personnel in this category are paid at a GS 11
level. For the purposes of this estimate, we have assumed a pay level
of GS 11, Step 3. We set the basic wage at $25.70 per hour, and a
benefit of 30% for a total hourly salary of $33.41 an hour (U.S. Office
of Personnel Management 2010 General Schedule (GS) Locality Pay Tables
for Atlanta; http://www.opm.gov/oca/11tables/indexgs.asp). In total,
the tests take about 13 hours (four hours in the BSL-4; three hours of
irradiation; and six hours running the test with interpretation).
However, we assume that the person working on this test will be
carrying on other duties simultaneously. Therefore, we assign one-third
of the 13 hours of work time to the fourth part, or $145.00 ($434.33/
3).
The fifth and final component is the administrative costs related
to test result collection and dissemination. The individual responsible
for the activities under this component is typically in a supervisory
position. The supervisor examines the assay to ensure that the positive
and negative tests (quality controls) are accurate, and to ensure that
the test was performed according to prescribed scientific standards.
The supervisor puts the results on a response form and sends the
results to the importer with a copy to CDC's Division of Global
Migration and Quarantine (DGMQ). To calculate this cost, we used half
an hour of the salary and benefits of a GS 14 level, Senior Health
Scientist (601 series). The hourly rate of a GS14, level 3 is $50 (U.S.
Office of Personnel Management 2010 General Schedule (GS) Locality Pay
Tables for Atlanta; http://www.opm.gov/oca/10tables/indexgs.asp). We
added 30% of the hourly rate for benefits to total $65.00. Thirty
minutes of this individual's time is $33.00.
Total cost: Adding these parts (Table 1) results in a grand total
of $540. We note that our results can potentially vary from this figure
for a couple of reasons. First, as mentioned already, commercial data
are not available for some of the reagents so our calculation of their
costs is an estimate and not based on observed market pricing. Second,
the costs will vary depending on how many tests are conducted at one
time. If multiple tests are run concurrently, then the costs would be a
bit less. If only one test is conducted at one time, the costs will be
relatively higher. Therefore, we set the cost of reimbursement per test
at $540. We feel confident that this is a fair price to the importers
because this amount is consistent with the sum charged by the
commercial lab of $500.00 that previously performed these tests. We
also note that our assumption of the effect of multiple tests is
supported by past experience. HHS/CDC receives notification of about
100 to 150 requests performed per year. Although HHS/CDC cannot control
the flow of tests and cannot forecast how many tests will be underway
at any given point in time, HHS/CDC estimates that the total amount of
fees charged will range from about $50,000 to $75,000 per year. The
user fee charged for the testing will cover the costs of the test.
HHS/CDC will impose the user fee by schedule. An up-to-date fee
schedule is available from the Division of Global
[[Page 7113]]
Migration & Quarantine, Centers for Disease Control and Prevention,
1600 Clifton Road, Atlanta, Georgia 30333, 404-498-1600, or [insert url
of Web site].
VII. Payment Instructions
HHS/CDC Importers should submit a check or money order in the
amount of $540.00 (USD) made payable to Centers for Disease Control and
Prevention for each test conducted at the time that specimens are
submitted to the CDC for testing. The check(s) should be sent to
Centers for Disease Control and Prevention, P.O. Box 15580, Atlanta, GA
30333.
VIII. Regulatory Analyses
A. Required Regulatory Analyses Under Executive Orders 12866 and 13563
We have examined the impacts of the proposed rule under Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages, distributive impacts, and equity). Because the
purpose of this rule is to provide a framework to determine a fair fee
to charge for a service that has become unavailable in private,
commercial markets within the United States, we have determined that
the rule will not violate the intent of either of the Executive Orders
because it will in no way prevent a private entity from entering the
field and providing a similar, privatized service. If any private
entity expresses an interest in providing this service, we will
strongly encourage them to do so.
B. Regulatory Flexibility Act
We have examined the impacts of the proposed rule under the
Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that
the rule is not expected to have a significant economic impact on a
substantial number of small entities, the Regulatory Flexibility Act,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA), requires agencies to analyze regulatory options that would
minimize any significant economic impact of a rule on small entities.
We certify that this rule will not have a significant economic impact
on a substantial number of small entities within the meaning of the
RFA.
C. Small Business Regulatory Enforcement Fairness Act of 1996
This regulatory action is not a major rule as defined by Sec. 804
of the Small Business Regulatory Enforcement Fairness Act of 1996. This
proposed rule will not result in an annual effect on the economy of
$100,000,000 or more; a major increase in cost or prices; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
companies to compete with foreign-based companies in domestic and
export markets.
D. The Paperwork Reduction Act of 1995
HHS/CDC has reviewed the information collection requirements of the
proposed rule and has determined that the information collection
requested in the proposed rule is already approved by the Office of
Management and Budget (OMB) under OMB Control No. 0920-0263, expiration
date 6/30/2014. The proposed rule does not contain any new data
collection or record keeping requirements.
E. National Environmental Policy Act (NEPA)
Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are
categorically excluded from the NEPA environmental review process),
HHS/CDC has determined that this action does not qualify for a
categorical exclusion. In the absence of an applicable categorical
exclusion, the Director, CDC, has determined that provisions amending
42 CFR 71.53 will not have a significant impact on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
F. Civil Justice Reform (Executive Order 12988)
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this proposed rule: (1) All State and local
laws and regulations that are inconsistent with this rule will be
preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
G. Executive Order 13132 (Federalism)
The Department has reviewed this rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' The rule does not ``have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
H. Plain Language Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
Government administers or enforces. HHS has attempted to use plain
language in promulgating this rule consistent with the Federal Plain
Writing Act guidelines.
I. Conclusion
In accordance with the provisions of Executive Order 12866, this
proposed rule was not reviewed by the Office of Management and Budget.
IX. References
1. Centers for Disease Control and Prevention. Update: Ebola-Related
Filovirus Infection in Nonhuman Primates and Interim Guidelines for
Handling Nonhuman Primates during Transit and Quarantine. Morbidity
and Mortality Weekly Report MMWR 1990; 39(2):22-24, 29-30.
2. Roper, W.L. Dear interested party (letter). March 15, 1990.
Available upon request: (404) 639-1600.
3. 55 FR 10288, March 20, 1990, ``Importation of Nonhuman Primates:
Meeting.''
4. Centers for Disease Control and Prevention. Update: Filovirus
Infection in Animal Handlers. Morbidity and Mortality Weekly Report
MMWR 1990; 39(13):221.
5. 55 FR 15210, April 20, 1990, Requirement for a Special-permit to
Import Cynomolgus, African Green, or rhesus Monkeys into the United
States.
6. Roper, W.L. Dear interested party (letter). October 10, 1991.
Available upon request: (404) 639-1600.
7. Ksiazek, Thomas G.; Rollin, Pierre E.; Jahrling, Peter B.;
Johnson, Eugene; Dalgard, Dan W., and Peters, Clarence J. Enzyme
immunosorbent assay for Ebola virus antigens in tissues of infected
primates. Journal of Clinical Microbiology. 1992; (304):947-950.
8. Ksiazek, Thomas G. Laboratory diagnosis of filovirus infections
in nonhuman primates. Laboratory Animal. 1991; 20(7):34-46.
9. Tipple, M.A. Dear interested party (letter). March 5, 1996.
Available upon request: (404) 639-1600.
10. Demarcus, T., Tipple, M., Ostrowski, S., U.S. Policy for Disease
Control among Imported Nonhuman Primates, J Infect Dis. (1999) 179
(supplement 1): S281-S282.
[[Page 7114]]
List of Subjects in 42 CFR Part 71
Communicable diseases, Public health, Quarantine, Reporting and
recordkeeping requirements, Testing, User fees.
For the reasons set forth in the preamble, HHS proposes to amend 42
CFR part 71 as follows:
PART 71--FOREIGN QUARANTINE
1. The authority citation for part 71 continues to read as follows:
Authority: Secs. 215 and 311 of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as
amended (42 U.S.C. 264-272); 31 U.S.C. 9701.
Subpart F--Importations
2. In Sec. 71.53, add paragraph (j) to read as follows:
Sec. 71.53 Nonhuman primates.
* * * * *
(j) Filovirus Testing Fee. (1) Non-human primate importers shall be
charged a fee for filovirus testing of non-human primate liver samples
submitted to the Centers for Disease Control and Prevention (CDC).
(2) The fee shall be based on the cost of reagents and other
materials necessary to perform the testing; the use of the laboratory
testing facility; irradiation for inactivation of the sample; personnel
costs associated with performance of the laboratory tests; and
administrative costs for test planning, review of assay results, and
dissemination of test results.
(3) An up-to-date fee schedule is available from the Division of
Global Migration & Quarantine, Centers for Disease Control and
Prevention, 1600 Clifton Road, Atlanta, Georgia 30333. Any changes in
the fee schedule will be published in the Federal Register.
(4) The fee must be paid in U.S. dollars at the time that the
importer submits the specimens to HHS/CDC for testing.
Dated: January 19, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-2841 Filed 2-9-12; 8:45 am]
BILLING CODE 4163-18-P